A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
- Conditions
- CeliacMalabsorption SyndromesCeliac DiseaseAutoimmune DiseasesIntestinal DiseaseGastrointestinal DiseaseDigestive System DiseaseGluten Sensitivity
- Interventions
- Biological: Nexvax2Biological: Placebo
- Registration Number
- NCT03644069
- Lead Sponsor
- ImmusanT, Inc.
- Brief Summary
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
- Detailed Description
A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 146
- Adults 18 to 70 years of age (inclusive)
- History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
- Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
- Willingness to consume a moderate amount of gluten
- Able to read and understand English
- Worsening of GI symptoms in response to an oral gluten challenge
- HLA DQ 2.5 positive
- Unwilling or unable to perform self-injections
- History of inflammatory bowel disease and/or microscopic colitis.
- Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
- Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
- Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
- Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
- Females who are lactating or pregnant
- Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nexvax2 Nexvax2 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. 79 to 93 days after baseline Measured by the CeD Patient Reported Outcome (CeD PRO) between baseline and day of the first masked food challenge (MFC) containing gluten. The CeD PRO captures patient ratings for a number of CeD-associated symptoms, on a 0 to 10 scale, with 0 being absent or no symptoms, and 10 being the most severe symptoms. The Total GI domain score is calculated as an average of summed average and individual symptom scores relevant to the GI tract, to yield a value of 0 to 10.
- Secondary Outcome Measures
Name Time Method Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten. 79 to 93 days after baseline Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten.
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains. 79 to 93 days after baseline Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten.
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms. 79 to 93 days after baseline Differences in each of the individual GI item scores in the CeD PRO between baseline and day of the first MFC containing gluten. GI symptoms assessed on the CeD PRO include abdominal cramping, abdominal pain, bloating, diarrhea, gas, loose stool, and nausea. Each are rated on a 0 to 10 scale, where 0 is absent and 10 is the most severe.
Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2. Study Duration: 21 weeks Treatment emergent adverse events (TEAEs) will be summarized by treatment arm, severity, relationship to study drug and to known or potential gluten exposure, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.
Trial Locations
- Locations (40)
PMG Research of McFarland Clinic
🇺🇸Ames, Iowa, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Southern Australia, Australia
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
P3 Research Limited
🇳🇿Mount Cook, New Zealand
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, United States
Celiac Disease Center at Columbia University
🇺🇸New York, New York, United States
UCMC - Center for Clinical Cancer Genetics and Global Health
🇺🇸Chicago, Illinois, United States
Great Lakes Gastroenterology Research
🇺🇸Mentor, Ohio, United States
PMG Research of Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Gastroenterology and Endoscopy Specialists
🇳🇿Christchurch, New Zealand
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Thomas Jefferson University Hospitals - Center City Campus
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Trials Centre - University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
Auckland Clinical Studies
🇳🇿Auckland, New Zealand
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Allegiance Research Specialists
🇺🇸Wauwatosa, Wisconsin, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
Coastal Carolina Research
🇺🇸Mount Pleasant, South Carolina, United States
Alliance Medical Research
🇺🇸Lighthouse Point, Florida, United States
Coral Sea Clinical Research Institute
🇦🇺Mackay, Queensland, Australia
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The Wesley Hospital - The Wesley Research Institute
🇦🇺Auchenflower, Queensland, Australia
ActivMed Practices & Research
🇺🇸Portsmouth, New Hampshire, United States
Digestive Health Research
🇺🇸Hermitage, Tennessee, United States
Advanced Research Institute
🇺🇸South Ogden, Utah, United States
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
🇦🇺Parkville, Victoria, Australia
Eastern Health-Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Ocean State Clinical Research Partners
🇺🇸Lincoln, Rhode Island, United States
The University of Queensland - Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia